Diabetes, Overweight and obesity
Conditions
Interventions
Group1:HSK34890 tablets 10 mg or placebo,single dose
Group2:HSK34890 tablets 30 mg or placebo,single dose in fasting and fed condition,crossover
Group3:HSK34890 tablets 60 mg or placebo,single dose
Group4:HSK34890 tablets 120 mg or placebo,single dose
Group5:HSK34890 tablets 240 mg or placebo,single dose
Group6:HSK34890 tablets or placebo,dose escalation,multiple dose
Sponsors
The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Subject must have signed a written informed consent prior to undertaking any research-related activity and must be able to understand the full nature and purpose of the trial, including the possible risks and adverse effects; 2. Male or femal, aged 18-55 years (inclusive of upper and lower limits) at the time of screening; 3. Body mass index (bmi) = 18.0 and = 28.0 kg/m2 and weight = 45 kg for women and = 50 kg for men at screening; 4. Subject (including partner) has no plans to have children and is willing to use highly effective contraception as specified in the protocol from 14 days prior to signing the informed consent until 6 months after the last dose;
Exclusion criteria
Exclusion criteria: 1. Abnormal findings on vital signs, physical examination, laboratory tests, calcitonin, chest X-ray, abdominal ultrasound and electrocardiogram which are judged by the investigator to be clinically significant; 2. Have a history of significant cardiovascular, respiratory, gastrointestinal, urological, haematological, endocrine, immunological or neurological disease or have any the above disease, including any acute illness or surgical procedure within the past 3 months that is judged by the investigator to be clinically relevant; 3. HbA1c = 6.0% and Fasting Plasma Glucose = 3.9 mmol/L or = 6.1 mmol/L during the screening period; 4. Abnormal liver function test results (e.g., aspartate aminotransferase [AST], alanine aminotransferase [ALT] and gamma-glutamyl transferase) that are clinically significant in the judgment of the investigator; and/or total bilirubin greater than 3 times the ULN; 5. Hepatitis B surface antigen (HBsAg), hepatitis C antibodies, syphilis antibodies, and human immunodeficiency virus (HIV) antibodies are positive at screening; 6. Previous history of clinical gastric emptying abnormalities (e.g. gastric outlet obstruction), severe chronic gastrointestinal disease (e.g. inflammatory bowel disease, active ulcer); 7. Having undergone gastrointestinal surgery that can cause malabsorption prior to screening, or having taken long-term medication that has a direct effect on gastrointestinal motility. For example, having undergone bariatric surgery or manipulation (e.g. gastric banding), or having used medication with weight-lowering effects (including but not limited to Orlistat) within 3 months prior to dosing, or a change in weight of more than 10% within 3 months prior to dosing; 8. Having medication that may affect glucose metabolism (e.g. systemic steroids, non-selective beta-blockers, monoamine oxidase inhibitors) within 1 month prior to screening; 9. Previous history or family history of medullary thyroid cancer, multiple endocrine adenomatosis type 2, previous history of pancreatitis or symptomatic gallbladder disease; 10. Persons who have consumed an average of >14 units of alcohol per week (1 unit of alcohol ˜ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) within 3 months prior to screening, or persons who are unable to abstain from alcohol during the trial, positive alcohol test results; 11. Persons with a history of substance abuse or drug use within 6 months prior to screening or positive drug abuse screening results; 12. Those who have smoked an average of more than 5 cigarettes per day within 3 months prior to screening or have used any tobacco product in the 48h prior to dosing; 13. Those who have excessive consumption of tea, coffee and/or caffeinated beverages (average of more than 8 cups, 1 cup ˜ 250 mL) within 3 months prior to screening; 14. Those who have consumed dragon fruit, mango, grapefruit, carambola or food or beverages prepared from them, or food or beverages containing xanthines, caffeine or alcohol (including chocolate, tea, coffee, cola, cocoa, etc.), or other special diets that interfere with the absorption, distribution, metabolism, or excretion of the drug within 48 h prior to admission; 15. Having used any prescription or over-the-counter medication (including herbal medicines, diet pills, etc.) within 14 days prior to the first administration of the test drug or within 5 half-lives of the drug, whichever is longer; 16. Known or suspected allergy to an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety outcomes (adverse events, vital signs, physical examination, routine blood, urinalysis, blood biochemistry, coagulation function, 12-lead ECG); | — |
Secondary
| Measure | Time frame |
|---|---|
| PK outcome ; | — |
Countries
China
Contacts
Public ContactHu Wei
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed